Monitoring movement in patients with ALS using a wearable device
Holter of Movement in Patients With Amyotrophic Lateral Sclerosis.
This study is testing a new wearable device to see how daily movement patterns change in people with ALS over a year.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 30 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Centre Hospitalier Universitaire de Liege Academic / other |
| Locations | 3 sites (Leuven and 2 other locations) |
| Trial ID | NCT06228001 on ClinicalTrials.gov |
What this trial studies
This observational study aims to assess the daily movement patterns of patients with amyotrophic lateral sclerosis (ALS) using a novel device called Actimyo. Approximately 30 patients will be enrolled and monitored every three months for a year, during which they will wear the Actimyo device daily for one month after each visit. Participants will undergo clinical examinations and various tests, including the 6-minute walk test and electromyography, to evaluate their motor function and overall health. The study seeks to gather data on the impact of ALS on daily living activities through continuous monitoring.
Who should consider this trial
Good fit: Ideal candidates for this study are adults over 18 years old with a clinically defined or probable diagnosis of ALS.
Not a fit: Patients with significant cognitive disorders or other conditions affecting motor function may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could provide valuable insights into the daily functioning of ALS patients, potentially leading to improved management strategies.
How similar studies have performed: While this approach is innovative, similar studies using wearable technology for monitoring ALS have shown promise in understanding disease progression.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Clinically defined or probable diagnosis of ALS according to El Escorial criteria revised with Awaji's electro-diagnostic algorithm. * Over 18 years old. * Signed informed consent * If patient on Riluzole, the dosage should be stable for 1 month and continued throughout the study period. Exclusion Criteria: * Patients with excessive cognitive disorders, limiting the understanding of task or with apparent communication difficulties hindering data collection. * Any other previous or present pathology having an impact on motor function. * Recent surgery or trauma (less than 6 months) in the upper or lower limbs. * Prior neurological, endocrine, infectious, allergic, or chronic or acute inflammatory pathology in the three weeks preceding inclusion. * Patients participating in an interventional clinical trial.
Where this trial is running
Leuven and 2 other locations
- Katholieke Universiteit Leuven — Leuven, Belgium (Recruiting)
- Centre de référence des maladies neuromusculaire, Centre Hospitalier Régional de la Citadelle — Liège, Belgium (Recruiting)
- Galaa Military Medical Complex — Cairo, Egypt (Active_not_recruiting)
Study contacts
- Principal investigator: Stéphanie Delstanche, MD — Centre de référence des maladies neuromusculaire, Centre Hospitalier Régional de la Citadelle
- Study coordinator: Laurie Medard
- Email: laurie.medard@citadelle.be
- Phone: +3243218222
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.